[Hiring] Regulatory Affairs SME @Tunnell Consulting

Role Description

One of our clients’ is seeking a Regulatory Affairs Subject Matter Expert (SME) with deep experience in soft gelatin (softgel) dosage forms to lead regulatory strategy and compliance activities. This role will support product development, commercialization, and lifecycle management across global markets. This is a remote project estimated for 6 months to support two sites, one based in North Carolina and the other in the Netherlands. Hours are estimated to be 20-40 hours/week.

• Serve as the Regulatory Affairs SME for soft gelatin (softgel) formulations and manufacturing operations
• Develop and execute regulatory strategies to support product development, commercialization, and lifecycle management activities
• Ensure compliance with U.S. FDA and global regulatory requirements (e.g., 21 CFR Part 111/210/211, labeling regulations) and post-approval change management expectations
• Review and approve product labels, claims, and marketing materials for regulatory compliance
• Support product registrations, submissions, and ongoing lifecycle management activities
• Partner cross-functionally with R&D, Quality, and Manufacturing to ensure regulatory alignment throughout development
• Assess regulatory impact of deviations, CAPAs, change controls, and manufacturing changes
• Provide regulatory guidance on formulation changes, manufacturing process updates, technical transfers, and global market entry
• Monitor and interpret regulatory changes and communicate impact to stakeholders
• Support audits, inspections, and regulatory inquiries
• Maintain accurate regulatory documentation and ensure audit readiness

Qualifications

• Bachelor’s degree in a scientific, regulatory, or related field (advanced degree preferred)
• 8+ years of Regulatory Affairs experience in pharma, biotech, or dietary supplements
• Strong expertise in soft gelatin (softgel) dosage forms required
• Deep knowledge of U.S. FDA regulations and relevant global requirements
• Experience with labeling, claims review, and compliance (supplements or OTC preferred)
• Familiarity with cGMP and manufacturing processes
• Proven ability to work cross-functionally and influence stakeholders
• Strong communication, analytical, and problem-solving skills

Requirements

• All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
• Please be advised that certain client contracts may outline specific requirements for onsite work.
• Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.